Comparison between the two transobturator inside-out procedures for the surgical treatment of female stress urinary incontinence: A randomised clinical trial

ISRCTN	ISRCTN65635093
DOI	https://doi.org/10.1186/ISRCTN65635093
Protocol serial number	2010/EC/23, EC 2003/23
Sponsor	University Hospital of Sart Tilman (CHU de Sart Tilman) (Belgium)
Funder	University Hospital of Liège (Belgium)

Submission date: 07/02/2010
Registration date: 26/03/2010
Last edited: 04/10/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof David Waltregny
Scientific

Service d'Urologie
Bloc Central
Batiment B35 -1
Centre Hospitalier Universitaire (CHU) de Sart Tilman
LIEGE
B-4000
Belgium

Study information

Primary study design	Interventional
Study design	Randomised two arm single blind controlled parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Clincial comparison between the original TVT-O and a modified procedure (mini TVT-O) for the surgical treatment of female stress urinary incontinence: A randomised clinical trial with 1-year follow-up
Study acronym	TVT-O versus mini TVT-O
Study objectives	A shorter transobturator tape placed inside-out with minimized dissection would result in similar cure rates as those obtained with the original inside-out transobturator procedure, but may result in less post-operative pain and complications.
Ethics approval(s)	The Ethics Committee of University Hospital of Liege (Comité d'Ethique Hospitalo-Universitaire de Liège) approved on the 10th of October 2006 (ref: amendment #3 to EC approval # 2003/23)
Health condition(s) or problem(s) studied	Female stress urinary incontinence
Intervention	Surgical treatment: original inside-out transobturator tape (TVT-O™) versus a modification of the procedure, with no perforation of the obturator membrane and a shorter tape length. The procedure lasts approx 15 minutes. The total duration of follow up is 12 months
Intervention type	Other
Primary outcome measure(s)	1. Objective and subjective cure of stress urinary incontinence at 1 year, measured by 1.1. Cough test (objective cure) 1.2. Measurement of Urinary Handicap (MUH), a validated self-administered questionnaire 2. Complication rates during a 1-year follow-up period, assessed by clinical examination and patient reporting at visits
Key secondary outcome measure(s)	Incidence and severity of postoperative pain at baseline, 1 day, 1, 6 and 12 months, measured by Visual Analogue Score (VAS) - inner thigh pain assessed for each side, left and right
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Female
Target sample size at registration	168
Key inclusion criteria	1. Age between 25 and 85 years 2. Clinical and urodynamic diagnoses of Stress Urinary Incontinence (SUI) 3. Positive stress test 4. Maximum cystometric capacity 300 ml or greater
Key exclusion criteria	1. Urodynamically proven detrusor overactivity 2. Impaired bladder contractility 3. Post void residual (PVR) 100 ml or greater 4. Contraindication to anaesthesia 5. Pregnancy 6. Neurogenic bladder 7. Active urinary or vaginal infection 8. Concomitant symptomatic and/or significant (more than second degree) pelvic organ prolapse (POP) 9. Patient not willing or unable to participate in the trial
Date of first enrolment	01/01/2007
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

Belgium

Study participating centre

Service d'Urologie

LIEGE
B-4000
Belgium

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes